The Union health ministry has accorded permission to three cancer drugs—Obinutuzumab injection, Pertuzumab and Afatinib—for importing and marketing in India without local clinical trial on Indian population on the plea that these drugs come under the category of 'the drugs indicated for diseases for which there is no therapy' in the country at present.
As per the Union health ministry's new directive, which was based on the recommendation of Prof Ranjit Roy Chaudhury committee report, “The waiver of clinical trial on Indian population for approval of new drugs, which have already been approved outside India, can be considered only in cases of national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/diseases for which there is no therapy”
According to sources, the Apex Committee of the health ministry in its meeting held recently has already given its approval for manufacture/import for marketing these drugs in the country without any local clinical trial.
While Obinutuzumab injection in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL), Pertuzumab is indicated for the treatment of positive metastatic or locally recurrent unresectable breast cancer who have not received previously treatment or whose disease has relapsed after adjuvant therapy. Afatinib is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation.
“Obinutuzumab injection has been approved in the US, Australia, Switzerland & Ecuador. Based on the fact that the drug got an orphan drug status in the US and Europe 'and it is a rare disease, therefore clinical trial waiver can be granted. Committee after detailed deliberation recommended for the marketing authorisation of the subject drug for the indication "Obinutuzumab in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL)" with the condition that "the safety data of the subject drug with respect to Indian patients shall be examined by the experts of SEC-Oncology after one year of marketing and the continuation of marketing authorization of the subject drug shall be considered after satisfactory evaluation of the PMS data by the experts". The drug is to be sold by the prescription of the 'Oncologist & Haematology'”, the Subject Expert Committee (SEC) recommended which was accepted by the Technical Committee, another two high-level committees constituted by the health ministry to screen the clinical trial applications on the directive of the Supreme Court.